MIDDLETON, Wisc.—Lucigen Corp. has announced that it has
received $2.8 million from the National Institutes of Health in a Small
Business Innovation Research (SBIR) grant to fund the research and development
of a point-of-
care diagnostic test for influenza. The grant represents the
company's largest SBIR Phase II grant to date, and the funding will be used to
develop a
point-of-case diagnostic testing device for influenza A, B and
respiratory syncytial virus (RSV).

"As a pioneer in cloning, enzyme discovery and metagenomic
studies, Lucigen is now set to leverage its previous breakthroughs into
real-world
healthcare applications. We plan the world's first nucleic
acid-based test for viral infections that is cost-effective and can be safely
and easily
used directly at the physician's office, eliminating the need to
send the sample off to central testing laboratories," David Mead, Ph.D.,
founder and
CEO of Lucigen, said in a press release. "DNA or RNA based tests have
repeatedly shown greater sensitivity and specificity over commonly used 'rapid
'
immunochemistry-based testing methods, but have not been simplified to the
extent that they can be moved to a POC situation. Our solution has the
potential to significantly advance sensitivity and time to results, thus
improving patient treatment and outcomes."

Though respiratory infections consistently have a
significant presence worldwide, current test products for the diagnosis of
such
infections, including influenza, do not offer diagnosis in the timeframe ideal
for implementing antiviral treatments. With the receipt of this
grant, however,
Lucigen will work to develop a device and reagents for the molecular diagnosis
of multiple RNA pathogens to facilitate a faster
standard for patient
diagnosis.

The key for such technology will be the development of a
novel
enzyme capable of converting RNA to DNA and isothermally amplifying it in
a matter of minutes, characteristics that allow for a device that does not
require microfluidics, pumps or valves. Such a technology is ideal for both
low-resource and battlefield settings, the company noted in a press
release,
with additional long-term potential as an over-the-counter device.

The grant is the
second large SBIR grant that Lucigen has
received this year. In early March, Lucigen announced that it had been awarded
a SBIR Phase II grant of $2.5
million for the development of metagenomic DNA
libraries for the identification of antimicrobial and anti-infective drug
candidates. The grant supports
Lucigen's ongoing work in the realm of
metagenomics, as with a previous Phase I grant, the company worked with
scientists from Auburn University to create a DNA library from soil microbes,
an effort
that resulted in 28 new compounds that inhibit the growth of
methicillin-resistant Staphylococcus aureus (MRSA).

The company's partners for the Phase II SBIR grant are
Auburn University and the University of Mississippi. Together, the partners
will create several large metagenomic libraries,
which will then be screened
for antimicrobial activity against four multiple-drug resistant pathogens. Lead
candidates that display high potency
against multiple pathogens will then be
evaluated for efficacy via an in-vivo
MRSA assay. The resulting libraries will also offer a resource
for researchers
scanning for anticancer, antifungal or antiviral compounds.